The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer

Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.

Eligibility

Ages Eligible for Study:

21 Years to 74 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Preoperative criteria:

Histologically confirmed adenocarcinoma

Clinical stage II or III

Preoperative findings:

Main lesion of the tumor is located at the rectum

Lower tumor margin is below the peritoneal reflection

No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)

No invasion to other organ (s)

Patient age is more than 20 and less than 75

PS: 0, 1

No past history of chemotherapy, pelvic surgery or radiation

Written informed consent

Operative criteria:

Mesorectal excision is performed

Operative findings:

Main lesion of the tumor is located at the rectum

Lower tumor margin is below the peritoneal reflection

R0 after resection

Exclusion Criteria:

Multiple cancer patients

Pregnant patients

Psychological disorder

Steroid administration

Cardiac infarction within six months

Severe pulmonary emphysema and pulmonary fibrosis

Doctor's decision for exclusion

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190541